FDA advisory panel recommends reduced restrictions on Avandia

Three years ago, the U.S. Food and Drug Administration found itself at the center of a controversy that eventually led it to severely restrict patient use of a top-selling type-2 diabetes drug. Now, in an unusual move, an agency advisory panel has re-opened the case and voted to recommend expanding the drug's availability, though some experts contend that it is still too dangerous for broad use.

Forbes reports that the FDA advisory panel only just narrowly voted to recommend loosening restrictions on the use of the diabetes drug rosiglitazone (Avandia). The vote could be a modest victory for the drug and its maker, GlaxoSmithCline, following years of scrutiny.

According to CBS News, the Avandia controversy began in 2007 when prominent Cleveland Clinic cardiologist Dr. Steven Nissen published an article in the New England Journal of Medicine suggesting that the drug increased a patient's risk of heart attack by 43 percent. Two years later, GSC published a clinical trial, called RECORD, which disputed Nissen's warning. Researchers at the Duke Clinical Research Institute performed a re-adjudication of the trial and concluded that it was sound.

Forbes notes that both RECORD and its DCRI's re-adjudication were met with scrutiny. The trials were not double-blind, meaning patients and doctors knew if they taking or administering Avandia or something else, which could have impacted the results. A large amount of data was also missing. As for the DCRI's re-adjudication, researchers used dossiers supplied by GSK itself in its evaluation, so did not really review any new data at all. Eventually FDA restrictions cut Avandia's use by 99 percent.

Of course, if the FDA follows through with the advisory panel's new recommendations, all of this may be changing. According to Forbes, panel members praised the DCRI's re-adjudication and suggested that restrictions on rosiglitazone should be loosened, but not removed. They could not reach a consensus on how the restrictions should be modified, however.

In a GSK statement, company Chief Medical Officer James Shannon said that GSK appreciates the committee's "thorough examination of the RECORD results" and will continue to work with the FDA. He said GSK believes Avandia is a safe treatment for type 2 diabetes "when used for the appropriate patient."

Forbes reports that Nissen, who absent from the hearings, released his own statement in which he reiterated his belief that RECORD was flawed. He said that meta-analyses, including one from the FDA itself, and observational data indicate that Avandia could increase risk of heart attack by as much as 80 percent. "I'm relieved that Avandia will remain restricted," he said, adding that he questions "the wisdom of spending taxpayer dollars to try to resurrect" the drug.

Article sources

"Avendia: Even if FDA reverses restrictions, will diabetes drug make a comeback?" cbsnews.com, June 6, 2013, Amanda Cochran